The Centers for Disease Control and Prevention has gently dipped its official toe into concerns that there could be a link between COVID-19 vaccines and strokes.
A statement released Friday by the CDC concerning the Pfizer-BioNTech vaccine said the possibility exists of a link between the bivalent form of the vaccine and stroke, all the while insisting that Americans should be vaccinated.
So what is a bivalent vaccine? “The bivalent COVID-19 vaccines include a component of the original virus strain to provide broad protection against COVID-19 and a component of the omicron variant to provide better protection against COVID-19 caused by the omicron variant,” the FDA says on its website.
The FDA said the bivalent Pfizer vaccine is used as a booster for those who have had their initial vaccinations.
The CDC release said that the U.S. government has “safety monitoring systems” in place to detect “possible safety signals for vaccines.”
In this case, the release said, the CDC’s Vaccine Safety Datalink prompted agencies to launch an investigation into Pfizer-BioNTech’s bivalent COVID-19 vaccine.
The issue, it said, is “a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.”
“Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination,” the CDC release said.
The release said no such issue had been found with the Moderna bivalent vaccine. It cautioned that “these safety systems detect signals that could be due to factors other than the vaccine itself” and said no other monitoring system had raised the alarm.
The agency added that various studies using Medicaid and Veterans Affairs databases have shown no such concern, nor has research in other countries.
“Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public,” the CDC said, adding that “no change in vaccination practice is recommended.”
Pfizer offered a statement in reply to the CDC, according to Fox News.
“Pfizer and BioNTech have been made aware of limited reports of ischemic stroke that have been observed in the CDC Vaccine Safety DataLink (VSD) database in people 65 and older following vaccination with the Omicron BA.4/BA.5-adapted bivalent COVID-19 Vaccine by Pfizer and BioNTech.”
“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” the statement said.
“Compared to published incidence rates of ischemic stroke in this older population, the companies to date have observed a lower number of reported ischemic strokes following the vaccination with the Omicron BA.4/BA.5-adapted bivalent vaccine.”
Dr. Marc Siegel, a Fox News medical contributor, said the CDC’s release is not proof of a link between the vaccine and strokes.
“This is not proof. This is that they see there may be a link here, and they want to investigate it, and they’re trying to be transparent,” he said.
Republican Washington Rep. Cathy McMorris Rodgers called for the CDC and FDA to “rapidly investigate, in an open and transparent manner, whether or not the vaccine may have contributed to the reported strokes,” according to Politico.
“If there’s one lesson that the CDC and FDA should have taken away from the pandemic, it’s the importance of providing honest, clear, precise, and timely information to the American people about the potential risks and benefits of COVID-19 interventions, including vaccination,” she said.
